Drug delivery is the method or process of administering an active pharmaceutical ingredient (“API”) to achieve a therapeutic effect in humans or animals. The most common routes of administration include the peroral (through the mouth), topical, transmucosal (nasal, buccal/sublingual, vaginal, ocular and rectal), intra-muscular injection, arterio/venous injection, and inhalation.
Historically, pharmaceutical compositions have primarily consisted of simple, fast-acting chemical compounds. More recently, however, formulations that control the rate and period of drug delivery have become increasingly common and complex.
Current methods of drug delivery exhibit specific problems. For example, many API's potencies and therapeutic effects are limited or otherwise reduced because of the partial degradation that occurs before these APIs reach a desired target. This partial degradation can lead to a need for increased dosages in an attempt to reach a therapeutically acceptable level of available drug. This, in turn, can lead to an increase in side effects and adverse events.
Accordingly, there has been a long felt un-meet need to create an economical, stable drug delivery system that overcomes the need for heat and mechanical energy in its preparation, while at the same time increasing the bioavailability of APIs without altering the API itself, and while obtaining the goal of delivering the API at the lowest therapeutically acceptable level.